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Tyrosine Kinase Inhibitor
Ensartinib for Cancer
Phase 2
Recruiting
Led By Meredith S Irwin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment
Stem cell Infusions (with or without total body irradiation [TBI])
Must not have
Patients who have an uncontrolled infection
Anti-GVHD agents post-transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years
Awards & highlights
Summary
This trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations.
Who is the study for?
This trial is for children and young adults up to 21 years old with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic changes (ALK or ROS1) and haven't responded to previous treatments. Participants need normal organ function, must be able to swallow capsules, and can't have had ensartinib before.
What is being tested?
The study tests how well the drug ensartinib works on patients with certain recurrent or refractory cancers. It includes various imaging studies like MRIs and bone scans to monitor the effects of the treatment which aims at blocking enzymes important for cancer cell growth.
What are the potential side effects?
While not explicitly listed in your information provided, drugs like ensartinib typically may cause side effects such as fatigue, nausea, liver issues (elevated liver enzymes), vision problems, muscle pain, weight gain due to fluid retention and potential heart issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 21 years old.
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I have had a stem cell transplant, with or without full body radiation.
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I can swallow pills without any issues.
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My body surface area is at least 0.5 square meters.
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I have not undergone radiopharmaceutical therapy.
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My kidney function, measured by creatinine clearance or GFR, is normal or above.
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I have received external beam radiation therapy.
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My bilirubin levels are within the normal range for my age.
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I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation.
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I am mostly able to care for myself and carry out daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any infections that are currently uncontrolled.
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I am taking medication to prevent graft-versus-host disease after a transplant.
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I am currently taking corticosteroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate
Secondary study objectives
Percentage of patients experiencing grade 3 or higher adverse events
Pharmacokinetic (PK) parameters
Progression free survival (PFS)
Other study objectives
Biomarkers as predictors of response to ensartinib
Changes in tumor genomic profile
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ensartinib)Experimental Treatment11 Interventions
Patients receive ensartinib PO QD on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Radionuclide Imaging
2004
Completed Phase 2
~50
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Bone Scan
2015
Completed Phase 2
~50
Ensartinib
2017
Completed Phase 2
~50
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,872 Previous Clinical Trials
41,010,648 Total Patients Enrolled
Children's Oncology GroupNETWORK
458 Previous Clinical Trials
239,813 Total Patients Enrolled
Meredith S IrwinPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any infections that are currently uncontrolled.You have had an organ transplant in the past.I am between 12 and 21 years old.I have had a stem cell transplant, with or without full body radiation.I have recovered from side effects of my previous cancer treatments.I can swallow pills without any issues.I am currently taking or have taken anti-cancer medication.I have recovered from side effects of my previous cancer treatments.I am not currently taking any experimental medications.I am taking other medications.I am not taking any strong CYP3A4 inhibitors or inducers.My body surface area is at least 0.5 square meters.Your blood has enough albumin (a type of protein) at a level of 2 grams per deciliter or higher.I am taking medication to prevent graft-versus-host disease after a transplant.I have not undergone radiopharmaceutical therapy.My cancer can be seen on scans, or if I have neuroblastoma, it shows up on a special scan.I have not been treated with ensartinib, but may have had other ALK inhibitors if it's been long enough since the last dose.My kidney function, measured by creatinine clearance or GFR, is normal or above.I have received external beam radiation therapy.My bilirubin levels are within the normal range for my age.Your SGPT (ALT) level in your blood is not higher than 3 times the normal limit.I am currently taking corticosteroids.I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation.I am mostly able to care for myself and carry out daily activities.My solid tumor does not affect my bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ensartinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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